Gottlieb: Immediate Release Opioids to be Subject to REMS
By Michael Mezher -
Published 28 September 2017
FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids.
Categories: News, US, FDA, Prescription drugs
Tags: Opioids, Immediate Release Opioids, IR, REMS, Risk Evaluation and Mitigation Strategy
RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation
By Zachary Brousseau -
Published 07 April 2017
Increasingly, regulatory professionals are involved in making organizational business decisions, yet few have formal business training. RAPS' Executive Development Program was designed to help them hone their business, management and leadership skills.
Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Education, Career Development
Tags: Executive Development Program, executive, executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
House Committee Probes Restricted Distribution Systems Delaying Generics
By Michael Mezher -
Published 24 March 2017
The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition.
Tags: REMS, Risk Evaluation and Mitigation Strategy, Restricted Distribution, Bioequivalence Studies
Why Regulatory Professionals Need Business Training
By William C. Putnam, PhD, RAC -
Published 02 March 2017
Because regulatory decisions have a direct impact on business outcomes, regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training.
Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Career Development
Tags: executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
Small Organizations, Big Regulatory Strategy
By Angela Johnson, MSE, PMP, RAC -
Published 30 January 2017
This article discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses also can learn from their innovative approaches. These include navigating incentives, understanding and utilizing technology tools for regulatory intelligence like social media and crowdsourcing, and embracing a team mentality to build agile and efficient regulatory programs with a strong underlying alignment with business development.
Categories: Features, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration
Tags: Regulatory Strategy, SMEs
Evolving Partnership: EMA Looks to Expand Work With Academia
By Zachary Brennan -
Published 01 February 2016
The European Medicines Agency (EMA) is intent on establishing a firmer framework for its work with academia as the agency needs to keep abreast of advances in science and continue to hone its regulations.
Categories: News, Europe, EMA, Biologics and biotechnology, Business Skills, Clinical, Combination products, Drugs, Regulatory intelligence, Regulatory strategy
Tags: EMA, academic collaborations, EMA strategy
EU's New Centralized Pharmacovigilance Portal Gets Endorsement from EMA
By Michael Mezher -
Published 12 June 2015
A year from now, drugmakers in the EU will be required to submit postmarket safety reports to an online central repository, the European Medicines Agency (EMA) has confirmed.
Categories: News, Europe, EMA, Drugs, Postmarket surveillance
Tags: Pharmacovigilance, EU Telematics Strategy, Periodic safety update reports, PSURs
Out of Africa: Six Regulatory Articles that Span the Continent
By Janet Aker, Managing Editor, Regulatory Focus -
Published 16 February 2015
Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southern Africa, West Africa, Central Africa, Northern Africa and South Africa. The articles contain the regulatory agency contacts/responsible parties for countries in each geographic area. The collection also includes an articles on RCOREs.
Categories: Features, Africa, Drugs, Government affairs, Project management, Submission and registration
Tags: Africa, South Africa, Northern Africa, North Africa, West Africa, Central Africa, East Africa, Southern Africa, RCOREs, regional centres of excellence, submission, submission and registration, dossier, regulatory submission, regulatory training, regulatory strategy, WHO, NEPAD, East African Community, EAC, regulatory challenges, harmonization, ministry of health, ministere de la sante
What's the Best Time to Submit a 510(k) Application to FDA?
By Sharon DeGrove Bishop, RAC -
Published 16 July 2014
What if there was a particular month when your submission would be cleared faster than any other month? Wouldn’t it be great to know that your submission is going into the US Food and Drug Administration (FDA) at the optimal time?
Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration
Tags: 510(k), 510(k) Filing, Best Time to Submit 510(k), 510(k) Filing Strategy, 510(k) Review Times, RIQ, Regulatory Intelligence Quotient
Australian Regulators Lift Ban on HIV Self-Test Kits
By Louise Zornoza, RegLink -
Published 11 July 2014
Following a public consultation, Australia’s Therapeutic Goods Administration (TGA) has announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests.
Categories: News, Oceania, TGA, In vitro diagnostics, Medical Devices
Tags: HIV, HIV Self-Test Kits, National HIV Strategy, Australia
RAPS Seeks Authors for Global Device Strategy Book
By Pam Jones, senior publications editor -
Published 27 March 2014
RAPS is seeking professionals with multinational experience with medical devices, throughout the lifecycle to authoring chapters for a new publication, Global Strategy for Medical Devices.
Categories: Medical Devices, Under RAPS
Tags: call for authors, Publication, strategy, book, global, regulatory
Regulatory Strategy 101
By Meredith Brown-Tuttle, RAC -
Published 19 March 2012
Regulatory strategy incorporates the drug development plan, outstanding issues or questions, background information, regulations and/or guidance documents, strategic advice, past precedents (if any) and recommendations on implementation. This article explores the basics of regulatory strategy and how regulatory professionals can best use it.
Tags: 101, strategy, plan, regulatory
Demystifying CMC Regulatory Strategy for Biologics - Part 3: An Effective CMC Regulatory Strategy Is Possible
By John Geigert, PhD, RAC -
Published 06 February 2012
Note: Demystifying, according to Merriam-Webster's dictionary, is "to remove the mystery or mystique; to make rational or comprehensive." This is the third part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; Part 2 examined the major differences between biologics and chemical drugs; and Part 4 will examine the challenge of adventitious agent contamination control for biologics. Failures in the chemistry, manufacturing and controls (CMC) regulatory strategy for biologics abound: a recombinant enzyme is delayed in gaining market approval because the US Food and Drug Administration (FDA) concludes that "the commercial process is not representative of the Phase 3 material used to establish the safety and efficacy profile; "a recombinant protein is rejected by the European Medicines Agency (EMA) because "with regard to Quality a large number of outstanding issues remained" (e.g., lack of product comparability, insufficient stability data, manufacturing process not adequately validated); a recombinant protein is withdrawn from the US market because a "minor change in the formulation" leads to spontaneous syncope (fainting).
Categories: EMA, FDA, Manufacturing
Tags: Chemistry, Perspective, strategy, controls, Biologics, CMC, risk, regulatory